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Acute Myocardial InfarctionAMI-CIDSSNCT07367399

Acute Myocardial Infarction Clinical Intelligent Decision Support System

An observational study of Acute Myocardial Infarction and Large Language Models, run by Beijing Anzhen Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Acute Myocardial Infarction (AMI) remains the leading cause of cardiovascular mortality globally. In China, while the incidence of AMI is escalating at an annual rate of 5.2%, significant clinical challenges persist: diagnostic delays in primary care facilities exceed 40%, and the "Door-to-Balloon" (D2B) compliance… Read more about this study

Who is it for?
Ages 18 years and older
How many people
15,000 participants
Where
1 siteChina
Study dates
1 Jan 2018to 31 Dec 2028
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population comprised consecutive adult patients (aged ≥ 18 years) diagnosed with acute myocardial infarction (AMI) and admitted to Beijing Anzhen Hospital. AMI was defined according to the Fourth Universal Definition of Myocardial Infarction, encompassing both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). Inclusion required documented acute myocardial injury (rise/fall of cardiac troponin above the 99th percentile URL) alongside clinical evidence of ischemia. All participants provided written informed consent. We excluded patients with a life expectancy < 12 months due to non-cardiac comorbidities, those with severe cognitive impairment hindering assessment, and individuals unable to comply with the long-term follow-up protocol. The study was approved by the Institutional Ethics Committee and conducted in strict accordance with the Declaration of Helsinki.

Who may be able to join

  • Patients meeting the diagnostic criteria for acute myocardial infarction (AMI). Acute Myocardial Infarction (AMI) encompasses both ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI).
  • According to the Fourth Universal Definition of Myocardial Infarction, myocardial injury is defined as the detection of an elevated cardiac troponin (cTn) value above the 99th percentile upper reference limit (URL). The injury is considered acute if there is a rise and/or fall of cTn values.
  • The clinical definition of myocardial infarction (MI) requires the presence of acute myocardial injury, confirmed by abnormal cardiac biomarkers, in the setting of evidence of acute myocardial ischemia. Clinical evidence of ischemia includes at least one of the following:
  • ①Symptoms of myocardial ischemia;
  • ②New ischemic ECG changes;
  • ③Development of pathological Q waves;
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  • ④Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology;
  • ⑤Identification of a coronary thrombus by angiography or autopsy.
  • Patients who have provided written informed consent.

Who cannot join

  • patients with a life expectancy < 12 months due to non-cardiac comorbidities;
  • those with severe cognitive impairment hindering assessment;
  • individuals unable to comply with the long-term follow-up protocol

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital

    Beijing

Other trials in China

About this study

Acute Myocardial Infarction (AMI) remains the leading cause of cardiovascular mortality globally. In China, while the incidence of AMI is escalating at an annual rate of 5.2%, significant clinical challenges persist: diagnostic delays in primary care facilities exceed 40%, and the "Door-to-Balloon" (D2B) compliance rate in tertiary hospitals stagnates at a mere 65%. These figures underscore systemic deficiencies, including inefficient emergency response, regional resource disparities, and fragmented longitudinal care. Although Large Language Models (LLMs) provide a transformative technical foundation for AMI management, their clinical translation is hindered by critical bottlenecks, such as non-standardized data interfaces, limited model interpretability, inadequate hardware infrastructure at the grassroots level, and the inherent tension between data privacy and training requirements.

This research proposes a comprehensive implementation strategy for an AI-driven intelligent decision-making system for AMI. On a theoretical level, the study establishes a tripartite framework of "Technological Adaptation, Scenario Implementation, and Safeguard Mechanisms." By introducing a data governance scheme based on federated learning and multimodal fusion, and constructing a "Technical-Clinical-Economic" multidimensional evaluation model, this work bridges the theoretical divide between advanced technology and clinical practice. On a practical level, the study develops adaptive gateways and lightweight models to facilitate pervasive deployment in resource-constrained settings, optimizes the full-cycle clinical workflow to improve patient outcomes, and provides a scalable, replicable pathway for implementation.

Focusing on four core challenges-technological compatibility, clinical workflow integration, the balance between privacy and performance, and the establishment of scientific evaluation systems-this research aims to surmount existing translation barriers. It seeks to enhance the quality and efficiency of AMI care while providing a seminal reference for the clinical transformation of AI in other medical specialties.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    A composite endpoint comprising cardiac death, all-cause mortality, malignant arrhythmia, non-fatal recurrent myocardial infarction (MI), non-fatal stroke, unplanned repeat revascularization, and rehospitalization for heart failure.

    Measured: 1 year

Secondary outcomes (8)

  1. Cardiac Death

    Defined as death resulting from a primary cardiac cause (e.g., acute MI, sudden cardiac death, heart failure, or cardiac procedures).

    Measured: 1 year

  2. All-cause Mortality

    Defined as death due to any cause, encompassing both cardiovascular and non-cardiovascular etiologies.

    Measured: 1 year

  3. Non-fatal Recurrent Myocardial Infarction (MI)

    Defined as a new myocardial infarction occurring after the index event. This includes three distinct patterns: extension of the original infarct, infarction in a region adjacent to the initial site, or a new infarction at a site distant from the original lesion.

    Measured: 1 year

  4. Non-fatal Stroke

    Consistent with the World Health Organization (WHO) definition, stroke is defined as a focal (or global) neurological deficit caused by vascular injury persisting for more than 24 hours. This includes both ischemic and hemorrhagic stroke (intracerebral, intraventricular, and subarachnoid hemorrhage).

    Measured: 1 year

  5. Unplanned Repeat Revascularization

    Defined as any non-elective readmission for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

    Measured: 1 year

  6. Rehospitalization for Heart Failure

    A complex clinical syndrome resulting from structural and/or functional cardiac abnormalities that lead to reduced cardiac output and/or elevated intracardiac pressures at rest or during stress. Diagnosis requires inpatient treatment for typical symptoms and signs, such as dyspnea, fatigue, and fluid retention (e.g., pulmonary congestion, systemic venous congestion, or peripheral edema).

    Measured: 1 year

  7. Target Lesion Revascularization (TLR)

    Defined as repeat percutaneous intervention or bypass surgery involving the target lesion, which includes the stented segment plus the 5 mm proximal and distal margins. The necessity for revascularization is indicated by: (1) target lesion stenosis >50% in the presence of objective evidence of ischemia; or (2) target lesion stenosis >70% regardless of clinical symptoms.

    Measured: 1 year

  8. Target Vessel Revascularization (TVR)

    Defined as any repeat percutaneous intervention or bypass surgery performed on any segment of the target vessel, including the target lesion, the proximal and distal segments of the main epicardial artery, and all of its branches.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
15,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07367399
Sponsor's protocol ID
kebingbing253
Acronym
AMI-CIDSS
Status last verified
Jan 2026
First submitted
18 Jan 2026
Last updated
26 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Large Language Models, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac and Cerebrovascular Events (MACCE) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07367399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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